RANITIDINE HYDROCHLORIDE- ranitidine hydrochloride injection 
Cadila Healthcare Limited

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Ranitidine Injection, USP

PRINCIPAL DISPLAY PANEL - 2 mL Vial Container Label

NDC 65841-763-02

Ranitidine Injection, USP

50 mg/2 mL (25 mg/mL)*

For IV or IM Injection, or IV Infusion

2 mL Single-Use Vial

Sterile 

Rx only

Zydus Pharmaceuticals

vial label

PRINCIPAL DISPLAY PANEL - 2 mL Vial Carton Label

NDC 65841-763-02

Ranitidine Injection, USP

50 mg/2 mL (25 mg/mL)*

For IV or IM Injection, or IV Infusion

10 X 2 mL Single-Use Vials

Rx only

Sterile 

Zydus Pharmaceuticals

carton label single-use

PRINCIPAL DISPLAY PANEL - 6 mL Vial Container Label

NDC 65841-764-06

Ranitidine Injection, USP

150 mg/6 mL (25 mg/mL)*

For IV or IM Injection, or IV Infusion

6 mL Multi-Dose Vial

Sterile

Rx only

Zydus Pharmaceuticals

Vial Label multidose

PRINCIPAL DISPLAY PANEL - 6 mL Vial Carton Label

NDC 65841-764-06

Ranitidine Injection, USP

150 mg/6 mL (25 mg/mL)*

For IV or IM Injection, or IV Infusion

6 mL Multi-Dose Vial

Sterile

Rx only

Zydus Pharmaceuticals

carton label multidose
RANITIDINE HYDROCHLORIDE 
ranitidine hydrochloride injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-763
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV) 5 mg  in 1 mL
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-763-0210 in 1 CARTON03/01/2013
12 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09153403/01/2013
RANITIDINE HYDROCHLORIDE 
ranitidine hydrochloride injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-764
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHENOL (UNII: 339NCG44TV) 5 mg  in 1 mL
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-764-066 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product03/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09153403/01/2013
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(65841-763, 65841-764) , MANUFACTURE(65841-763, 65841-764)

Revised: 7/2020
Document Id: 04683095-2650-46d9-81c9-356498f92422
Set id: 9268c1df-bcf3-4899-896d-044492802a33
Version: 6
Effective Time: 20200728
 
Cadila Healthcare Limited